Kornimate/medical-research-clean huggingface dataset:
the phase 2 study to evaluate the safety and efficacy of clevudine in patients with moderate covid-19

Conditions: COVID-19

Summary: the purpose of this clinical trial is to assess the safety and efficacy of clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate covid-19.


Eligibility criteria:
key inclusion criteria: 1. over 19 years of age 2. covid-19 confirmed by a real-time rt-pcr tests 4 days prior to clinical trial enrollment 3. patients with peripheral capillary oxygen saturation (spo2) greater than 94% at the time of screening 4. patients whose body temperature is measured according to the measured area without taking a fever reducer during screening: \[armpit of greater than 37.0 °c or an oral of greater than 37.2 °c; patients with rectum greater than 37.6 °c or eardrum greater than 37.5 °c\] (notes: although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.) 5. patients with evidence of lung invasions as a result of radiation tests exclusion criteria: 1. patients who need breathing device (for example, invasive ventilation, invasive mechanical ventilation, extra-corporeal membrane oxygenation). 2. patients who participated in other clinical trials related to covid-19. 3. patients who were administered drugs directly to covid-19 24 hours prior to the start of the study. 4. patients whose ast or alt has increased by more than 5 times the normal lab value.

Keywords: coronavirus disease-19(covid-19)
clinical trial examining the short and long-term effect of myofascial trigger points injection in low back pain patients

Conditions: Low Back Pain

Summary: the objective of this study is to examine the short and long-term effect of myofascial trigger point injections with either a local anesthetic or saline in patients with chronic low back pain presenting with myofasical pain syndrome.


Eligibility criteria:
inclusion criteria: * clbp of non-malignant origin, with or without accompanying leg pain, including patients with history of previous back surgery or trauma * mps as evident by at least one active mtp, located medial or lateral to the posterior iliac crest involving the gluteus maximus or medius, quadratus lumborum and erector spinae muscles * while not precluding the participation in the study, mtp in other areas will not make patients eligible * pain lasting for at least six months exclusion criteria: * any current motor weakness, but not sensory loss or abnormal reflexes in the lower limbs * any injection or nerve block in the low back in the last 6 months * local or systemic infection * bleeding disorder or the use of anticoagulation medications * known allergy to local anesthetics * poor understanding of written and spoken english or french
the efficacy and safety of hlx208 in adult langerhans cell histiocytosis (lch) and erdheim-chester disease (ecd) with braf v600e mutation

Conditions: Langerhans Cell Histiocytosis; Erdheim-Chester Disease; LCH; ECD

Summary: the purpose of this study was to assess safety, efficacy and pk in adult langerhans cell histiocytosis (lch) and erdheim-chester disease (ecd) given hlx208 (braf v600e inhibitor).


Eligibility criteria:
inclusion criteria: 1. volunteer to participate in the clinical study; 2. aged ≥ 18 years; 3. confirmed adult patients with lch and/or ecd with braf v600e mutation; 4. at least one measurable lesion as per percist v1.0; 5. expected survival time ≥ 3 months; 6. ecog score 0-2; exclusion criteria: 1. previous treatment with braf inhibitors or mek inhibitors; 2. a history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery; 3. severe active infections requiring systemic anti-infective therapy; 4. other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
praevoskin emulsion in the prevention of radiation induced dermatitis

Conditions: Prevention of Radiation Induced Dermatitis.

Summary: a phase 2 double blind randomised study of praevoskin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.


Eligibility criteria:
inclusion criteria: 1. female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy. 2. planned to receive 50 gy whole breast irradiation +/- boost to tumor bed. 3. ecog performance status 0-1. 4. capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control. 5. no co-morbidities known to affect radiotherapy reactions. 6. no co-existing acute or chronic skin disease. 7. no evidence of infection or inflammation of breast to be treated. 8. not receiving chemotherapy during radiotherapy course.biological therapy (e.g. herceptin) or hormone therapy will be allowed during the study. exclusion criteria: 1. chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation. 2. prior radiotherapy to any site. 3. collagen vascular disease. 4. diabetes mellitus requiring medication. 5. uncontrolled hypertension. 6. participation in other clinical study. 7. any contra-indicating to treatment with melatonin. 8. history of allergy to peanuts or fragrances. 9. history of severe allergic reactions (e.g. asthma).
effect on bronchodilation response and ventilation heterogeneity of different inhalation volumes in copd

Conditions: COPD; Lung Injury

Summary: during bronchodilator tests, it's common to ask patients with asthma or chronic obstructive pulmonary disease (copd) to take bronchodilator therapy by inhaling after a maximal exhalation, when the respiratory system volume equals the residual volume. the same maneuver is required for the chronic therapy. nevertheless, in patients with copd the distribution of ventilation is more heterogeneous, especially when lung volumes are closer to residual volume . it is therefore predictable that the distribution of air volume containing bronchodilator that has been inhaled at residual volume is more heterogeneous than at higher volumes, such as at functional residual capacity. accordingly, the bronchodilator can be preferentially distributed in more open airways than in less patent ones, with a heterogeneous distribution of the medication. therefore, the overall bronchodilation should be greater when the drug inhalation is performed at functional residual capacity than at residual volume. it is common knowledge that the effectiveness of bronchodilator therapy with pmdi in subjects with copd is greatly affected by the inhalation technique, which can be difficult to perform for many patients. therefore, in addition to the possibility that inhalation of bronchilation therapy at residual volume could lower the drug effectiveness, this maneuver complicates the sequence of actions required to the patient, enhancing the risk of errors and decreasing the aderence to treatment. the aim of this study is to investigate whether the inhalation of a bronchodilator at different lung volumes can affect its effectiveness in terms of respiratory function, in patients with copd. assuming that the bronchodilator effectiveness is equal or greater when inhaled at functional residual capacity rather than at residual volume, the inhalation maneuver can be simplified for patients with copd.


Eligibility criteria:
inclusion criteria: * age above 40 years old; * history of smoking equal or above 10 pkys; * vems after bronchodilatation ≤ 70%, * medical necessity to perform a bronchodilatation test. exclusion criteria: * history of bronchial asthma or other chronic respiratory diseases such as pulmonary fibrosis; * uncontrolled cardiovascular diseases at the time of the visit; * current pregnancy; * incapacity to execute lung function tests for cognitive impairment, substance abuse or claustrophobia; * known hypersensitivity or intolerance to salbutamol.
phase 3 study to evaluate iop lowering therapy in open angle glaucoma and ocular hypertension c-01-69

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility criteria:
adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (snellen equivalent) or logmar visual acuity not worse than 0.6. clinically relevant ophthalmic or systemic conditions may be excluded.

Keywords: open-angle glaucoma ocular hypertension poag
a first in human study of pf-00184562 in healthy volunteers

Conditions: Schizophrenia

Summary: the purposes of this study are: * to determine the safety, tolerability and pharmacokinetics of single doses of pf-00184562; and * to explore the exposure-response relationship of neuropsychometric and tolerability measures of pf-00184562 compared to olanzapine.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects of non-childbearing potential exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
phase 2a evaluation of pln-74809 on αvβ6 receptor occupancy using pet imaging in participants with ipf/

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a study in mild/moderate ipf patients using an αvβ6 pet ligand to evaluate target engagement.


Eligibility criteria:
inclusion criteria: * diagnosis of ipf, within 5 years prior to screening, * fvc %predicted ≥45%; historical fvc for entry in the study is permitted if within 1 month of screening. * dlco (hemoglobin-adjusted) ≥30%; historical dlco for entry in the study is permitted if within 1 month of screening. * participants receiving treatment for ipf with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months exclusion criteria: * currently receiving or planning to initiate treatment for ipf (fibrosis) with agents not approved for that indication by the fda * forced expiratory volume during the first seconds of the forced breath (fev1)/fvc ratio \<0.7 * clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect fvc measurement or ipf progression * known acute ipf exacerbation or suspicion by the investigator of such, within 6 months of screening * smoking of any kind within 3 months of screening
comparison of noninvasive vs. invasive hemodynamic measurements

Conditions: Heart Failure, Congestive

Summary: comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

the conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. to overcome this challenge, a new technology to assess cvp non-invasively using an oscillometric method is being developed. it is called enclosed zone central venous pressure (ezcvp). a comparison study of ezcvp and cvp is needed to determine accuracy and reproducibility.

Eligibility criteria:
inclusion criteria: 1. adult age over 18 years. 2. arm circumference is 18 cm to 55 cm 3. subject will have an existing indwelling central venous catheter during their icu stay 4. subject or legally authorized representative (lar) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent 5. subject or lar is willing and able to comply with protocol procedures exclusion criteria: 1. finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff. 2. pregnant (self-reported) 3. upper extremity deep venous thrombosis currently being treated 4. severe skin disease involving the upper arm(s) 5. study investigator may exclude patients based on clinical judgement
safety, pharmacokinetics, and preliminary efficacy of amx-500 in metastatic castration resistant prostate cancer (mcrpc)

Conditions: Hormone-refractory Prostate Cancer

Summary: the study will be conducted in 4 parts and will commence with dose escalation of amx-500 as a monotherapy (part 1), followed by monotherapy dose expansion (part 2). * part 1 (monotherapy dose escalation): single-agent amx-500 dose escalation * part 2 (monotherapy dose expansion): single-agent amx-500 dose expansion the study may subsequently continue via a protocol amendment with dose escalation of amx-500 combinations (part 3) followed by combination therapy dose expansion (part 4).

duration of the study up to approximately 48 months.

Eligibility criteria:
inclusion criteria: * has histological, pathological, and/or cytological confirmation of prostate adenocarcinoma or metastatic disease typical of prostate cancer (ie, involving bone or pelvic lymph nodes or para-aortic lymph nodes) * has metastatic disease, defined by ≥1 metastatic lesion that is present on baseline ct, mri, or bone scan imaging - has documented progressive mcrpc * have been treated with ≥ 1 prior taxane regimens (eg, docetaxel, cabazitaxel) * participants deemed unsuitable for standard of care * has eastern cooperative oncology group (ecog) performance status 0 to 1 * has a life expectancy more than 6 months exclusion criteria: * presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components * has acute or chronic infections * has a concomitant medical or inflammatory condition that may increase the risk of toxicity to amx 500, per the investigator * has lesions in proximity of vital organs * has known active cns metastases and/or carcinomatous meningitis the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: prostate cancer metastatic castration-resistant prostate cancer castration resistant prostatic cancer
endometrial evaluation in cases of postmenopausal bleeding

Conditions: Postmenopausal Bleeding

Summary: the aim of this prospective observational study is to evaluate abnormal uterine bleeding in postmenopausal women using 3d(dimensional) ultrasound assessment of endometrial volume .doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy

postmenopausal bleeding (pmb) is defined as vaginal bleeding occurring after twelve months of amenorrhoea, in a woman of the age where the menopause can be expected. hence it does not apply to a young woman, who has had amenorrhoea from anorexia nervosa, or a pregnancy followed by lactation. however, it can apply to younger women following premature ovarian failure or premature menopause, postmenopausal bleeding is a common problem representing 5% of all gynaecology outpatient attendances. postmenopausal bleeding is usually the first symptom of endometrial cancer and active intervention can lead to its early detection. so, there is need of a diagnostic tool with high accuracy for detection of endometrial pathology in most efficient and least invasive method possible. endometrial sampling is the gold standard for diagnosing abnormalities in the endometrial tissues ,however . there is a growing trend to use noninvasive procedures such as tvs, to measure the endometrial thickness, diagnose adenomyosis, endometrial polyps .another important ability of 3d tvs is volume calculation using the virtual organ computer-aided analysis (vocal) even in irregularly shaped structures. this method has been demonstrated to be more accurate than 2d-volume estimation . • hysteroscopy has the advantage of directly visualizing the uterine cavity and the endometrium, allowing biopsy to be taken immediately from the suspected abnormality.

Eligibility criteria:
* inclusion criteria: * women age \> 45 years * with postmenopausal uterine bleeding exclusion criteria: * women with bleeding disorders or coagulopathy * women with cervical cancer or breast carcinoma . * history of tamoxifen intake * women with fibroid .
hydrogen-infused water for endurance performance, body hydration biomarkers, and health-related quality of life

Conditions: Exercise Overtraining

Summary: the study investigates the impact of 4-week hydrogen-infused water consumption on various health and performance outcomes. conducted with healthy young adults, the trial assesses endurance performance, hydration biomarkers, and health-related quality of life. participants are randomized into intervention and control groups, with outcomes measured over a specified period. the findings aim to elucidate whether hydrogen-infused water water provides significant benefits for physical performance, hydration status, and overall well-being compared to standard hydration methods.


Eligibility criteria:
inclusion criteria: * age 18.0 - 29.9 years * body mass index 18.5 - 24.9 kg/m2 * collegiate athletes with training experience \>3 years * weekly exercise \> 5 hours * given written informed consent exclusion criteria: * major chronic diseases or acute disorders * history of dietary supplement usage in the 4 weeks preceding the study initiation * unwillingness to return for a follow-up * participation in other clinical trials

Keywords: endurance
multicenter study comparing osseospeed tx with osseospeed ev.

Conditions: Partial Edentulism in the Maxilla or in the Mandible

Summary: the purpose of this study is to evaluate the outcome of implant osseospeed ev compared to implant osseospeed tx with regards to marginal bone level changes and implant survival rate up to five years after implant loading. the hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent. 2. 18 -75 years at enrollment. 3. in need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws). 4. history of edentulism in the planned implant area of at least 3 months (at visit 2). 5. at least 4 months of healing after last grafting procedure in the planned implant area (at visit 2). 6. deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants. 7. deemed by the investigator to be suitable for loading after 6-8 weeks. 8. deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge. exclusion criteria: 1. unlikely to be able to comply with study procedures, as judged by the investigator. 2. uncontrolled pathological processes in the oral cavity. 3. untreated, uncontrolled caries and/or periodontal disease. 4. known or suspected current malignancy. 5. history of radiation therapy in the head and neck region. 6. history of chemotherapy within 5 years prior to surgery. 7. systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator. 8. uncontrolled diabetes mellitus. 9. corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration. 10. smoking more than 10 cigarettes per day. 11. present alcohol and/or drug abuse. 12. current need for bone grafting and/or augmentation in the planned implant area. local, minor soft tissue grafting will be allowed. 13. involvement in the planning and conduct of the study (applies to both astra tech staff and staff at the study site). 14. previous enrollment in the present study. 15. simultaneous participation in other clinical studies at enrollment (visit 1) and during the subject's first year of this study.
efficacy and safety trial with s 44819 after recent ischemic cerebral event

Conditions: Post Stroke Recovery

Summary: the purpose of this study is to assess the efficacy and safety of s 44819 in enhancing functional recovery after an ischemic stroke.


Eligibility criteria:
inclusion criteria : * patients aged between 18 and 85 years (both inclusive) * acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion exclusion criteria : * any non-selection criteria, which could have occurred after the selection visit * positive urinary or blood pregnancy test (for female patients of child bearing potential) * any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome * severe renal impairment detected in the local laboratory test * severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test * stroke due to cerebral venous thrombosis * brain mri showing a severe microangiopathy * brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct * qualifying ischemic cerebral event older than 192 hours at inclusion * any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome, * repeated prolongation of ecg qtcf * patient or authorised representative refusing to attend study visits or to take part in the study